BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTRAORAL BELSENSOR GOLD

    FDA 510(k)
    FDA Class 2 ·Dental

    VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600

    FDA 510(k)
    FDA Class 2 ·Radiology

    DR FOG TREATED SPONGE, STERILE

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·November 4, 2022

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·July 28, 2011

    PROXIMATE ILS CIRCULAR STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 17, 2014

    CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·May 17, 2017

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014